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Uzbekistan Amends Medicine Registration Regulation

On March 26, 2018, the amended Act on the State Registration of Medicines, Medical Devices and Medical Equipment entered into force in Uzbekistan introducing several important changes.

Namely, the new Act permits rights holders to import samples of medicines and medical products for research, testing and exhibition purposes without having to deal with registration formalities, which the old Act did not explicitly prescribe.

Under the new regulation, company’s registration certificate is no longer on the list of required documents, which removes another time-consuming step, especially when the applicant is a foreign company.

While the registration was previously carried out by the Main Department for Quality Control of Medicines and Medical Equipment within the Ministry of Health, it is now performed by the recently established Agency for the Development of the Pharmaceutical Industry, under the Ministry of Health.

The new regulation explicitly states that the following can be registered:

medicines (including medicinal substances);

new combinations of medicines already registered in Uzbekistan;

medicines already registered in Uzbekistan but produced in new forms or dosages or by other manufacturers;

medical products; and

medical equipment.

The registration process has shortened. Previously, the registration certificate was to be issued within 180 days from the date of receipt of the application, and now it varies depending on the type of product, namely:

50 days for medicinal substances;

120 days for medicines in the form of pre-packaged and packaged medicinal herbal raw materials, bandage materials, contraceptives, puncture, injection, transfusion, suction, first aid and patient care products, as well as rubber, latex and polymer medical products;

155 days for other medicines, medical products and medical equipment.

A registration certificate is still issued for a period of five years and the official fees remain the same — the application fee is EUR 175 (USD 213) and the fee for issuing a certificate is EUR 35 (USD 43).